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3 Agenda Introduction (brief) So what is involved in a clinical trial? Clinical Trial Process Good Clinical Data 3

4 Introduction - GCP Good Clinical Practice, Ethical studies (Declaration of Helsinki, regulations) 2. Risk-benefit must be acceptable 3. Rights, safety and well-being of subjects are paramount and prevail over science and society 4. Data should support the study (pre-clinical, clinical) 5. Protocol needed must be scientifically sound 6. Prior ethics committee approval of protocol 7. Qualified doctor (or dentist) is responsible for treatment and decisions 8. Staff must be adequately trained and qualified 9. Freely given informed consent before participation 10. Data should be properly recorded, handled and stored (5 years) 11. Confidentiality and privacy should be maintained 12. Drugs should be manufactured according to GMP and follow the protocol 13. Quality procedures should be applied throughout the trial process 4

5 Introduction - Goal of Clinical Trials (NIH website) Develop knowledge Voluntary participation and right to withdraw By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses. 5

12 Clinical Trial Process - Finance and Communication For a trial to provide good clinical data, it must be supported by adequate finance Sufficient staff (including monitoring) Centre payments Communication is key Regular communication is vital To allow proper risk management To ensure the protocol is followed 12

14 Clinical Trial Process - Clinical Trial Regulation In 2016, the EU Clinical Trials Regulation will come into effect It will supersede the CT directive (2001/20) and the GCP directive (2005/28) It will provide a simplified coordinated approval process It will depend upon an electronic portal for submissions and will therefore only take effect 6 months after the portal has been deemed fit for purpose 14

18 Clear records (future understanding) Good patient records at site Complete and accurate ISF If it s not written down, it didn t happen! The sponsor must have adequate oversight of the trial Regular monitoring o SDV o ISF o Training o Pharmacy Good Clinical Data - Monitoring o Identify as yet unreported SAEs Identification of protocol deviations and potential serious breaches Issue identity and escalation to the sponsor 18

19 Good Clinical Data - Auditing In addition to routine monitoring, auditing enables further confidence in the integrity of the data and ensures homogeneity between centres Routine auditing For-Cause auditing Competent Authorities can inspect centres Part of GCP inspections for the Sponsor (eg MHRA GCP inspection) To investigate serious breaches or fraud Good to be inspection ready Files and data up to date Training records complete 19

21 Good Clinical Data - Data integrity To ensure data integrity it is important that: Good documentation practices are followed for source data and records Systems are validated Process in place to ensure data quality and -security 21

23 Good Clinical Data - Why is CSV important? Can I trust the data generated? Accuracy Reliability Integrity can t be modified Availability for staff and inspectors Authenticity is it from the correct person Does the system do what it is meant to do? 23

24 Good Clinical Data - Fit for Purpose Validation (ICH 5.5.3(a)) It is expected that systems are validated to accepted standards, additionally, principles of CSV should be applied to study specific builds/programs/applications, particularly: Specifications Testing against specifications Approval and release Change control 24

29 Validation run FLOWCHART Manual discrepancy check Query to site Good Clinical Data - Data query and data cleaning cycles Answer provided (authorized) Answer processed No change: accepted as is Change: update of database Query: still unclear or new question(s) have risen Validation run Documentation 29

30 All trials must be entered into a public register before the first patient is entered, to allow future publication Clinicaltrials.gov Good Clinical Data - Analyse and publish data EudraCT register https://eudract.ema.europa.eu During the trial, the data must be analysed as appropriate IDMC Interim analyses (stopping rules) Continued assessment of risk Pharmacovigilance After the end of the trial, the results must be uploaded onto a public database Open access (as above) Publications 30

31 End of trial notifications EC and CA Declaration of the end of a clinical trial Form within 90 days of the end of the trial (define in the protocol last subject, last visit) Submit Clinical Study Report within 1 year Close centres Archive TMF and ISF (for 5 or 15 years note 25 years in new CT Reg) Archive database Good Clinical Data - End of trial 31

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This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

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